Biomedical Engineer – Diagnostic Ultrasound

Job not on LinkedIn

🔥 10 hours ago

🦀 Maryland – Remote

🦀 Maryland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Tunnell Consulting, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1962

🏛️ Government

🏥 Healthcare

💼 Consulting

Government • Healthcare • Consulting

Tunnell Consulting, Inc. is a government-focused consulting and services firm that provides scientific, technical, and project management expertise to federal agencies. The company’s offerings (branded as Tunnell Government Services) emphasize public health preparedness and response—helping defend the U. S. against major health threats—and scientific project portfolio management across all phases of R&D, including medical product development and portfolio oversight. They also provide staffing solutions to support government clients and transform organizations to meet agency missions.

📋 Description

• Conduct comprehensive technical and scientific reviews of medical device submissions, including 510(k), PMA, Pre-IDE, IDE, De Novo, and 513(g) submissions • Evaluate diagnostic ultrasound systems, associated software, and related technologies for safety, effectiveness, performance, and clinical utility • Provide subject matter expertise in ultrasound physics, acoustic output, imaging performance, and clinical applications of diagnostic ultrasound • Assess device design, engineering documentation, acoustic performance, software functionality, testing methodologies, validation activities, and risk management documentation • Review technical reports, engineering analyses, verification and validation data, computational modeling studies, and supporting scientific documentation • Support postmarket surveillance and compliance activities, including evaluation of MDRs, recalls, EIRs, EPRC issues, and trade complaints • Investigate device performance concerns, adverse events, technical deficiencies, and reported product failures involving marketed devices • Provide scientific and technical recommendations regarding device safety, risk assessment, benefit-risk determinations, and regulatory decision-making • Prepare written technical reviews, scientific assessments, memoranda, presentations, correspondence, and regulatory recommendations • Interpret and apply FDA regulations, guidance documents, consensus standards, and quality system principles • Collaborate with multidisciplinary teams of engineers, scientists, clinicians, and regulatory professionals

🎯 Requirements

• Bachelor's degree (B.S.) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Acoustics, Medical Physics, or a closely related technical discipline • Minimum of five (5) years of professional experience in biomedical engineering, ultrasound technology, acoustics, ultrasonics, medical devices, or a related field • Demonstrated research, development, or technical evaluation experience involving medical imaging devices and associated software • Experience supporting the research, development, testing, validation, or evaluation of diagnostic ultrasound hardware and/or software systems • Experience with artificial intelligence (AI) and machine learning technologies utilized in medical imaging applications, particularly within ultrasound or radiological imaging environments • Strong technical writing and communication skills, with the ability to prepare clear and well-supported scientific assessments and regulatory reviews • Must be a US Citizen or full Green Card holder • Preferred: advanced degree (M.S., Ph.D., or equivalent) in a related field • Preferred: advanced training, research, or specialized expertise in acoustics, ultrasound physics, biomedical instrumentation, therapeutic ultrasound, or imaging science • Preferred: experience evaluating innovative, emerging, or novel medical device technologies • Preferred: experience developing clinical evaluation strategies, performance testing plans, or clinical study protocols for medical devices • Preferred: knowledge of medical device risk management principles and methodologies • Preferred: experience supporting FDA-regulated medical devices in premarket review, quality systems, regulatory affairs, compliance, or postmarket surveillance • Preferred: familiarity with FDA-recognized consensus standards, guidance documents, and regulatory frameworks related to diagnostic ultrasound systems, medical imaging devices, SaMD, AI/ML-enabled devices, radiation-emitting products, and medical-device cybersecurity

🏖️ Benefits

• Full-time employee position • 100% telework / fully remote work arrangement • Employee-owned company • Monday–Friday schedule, excluding holidays

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume